FDA-AACR: Oncology Dose-finding Workshop Part III

Only
slides from presenters who have given permission will be included. Some
presenters have opted not to have their slides posted.

Given
the recent history of approvals based on the results of early phase
trials driven by extraordinary efficacy data, the incentive for
conducting rigorous dose-finding trials may not be overtly apparent.
However, the increasing need for the development of combination therapy
due to resistance to monotherapy and poor tolerance of approved dosing
regimens underscores the need for a more efficient process of dose
selection in the early stages of study design.

The FDA
and the AACR have successfully held Oncology Dose-finding Workshops in 2015
and 2016. Patient and dose selection of oncology drugs will be of
critical importance, as recent approvals of immune checkpoint inhibitors
(ICIs) and early, promising readouts from studies combining ICIs with
chemotherapy, targeted therapy, and other immuno-oncology agents will
put enormous pressures on the current clinical trial infrastructure of
the U.S. and the international community. A recent article in The Cancer
Letter reported that 803 clinical trials currently testing PD-1 and
PD-L1 drugs had over 160,000 slots for adult patients. As more ICIs
enter the market, additional trials will seek to combine these products
with standard of care therapies, novel small molecules, targeted
antibodies, and other biologic therapies such as vaccines and engineered
T-cells. This year’s workshop will focus on approaches to combination
therapy and best practices regarding patient and dose selection,
biomarkers to aid in selection, and novel endpoints that can define
patient benefit.